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NHRA Β· structured requirements

πŸ‡§πŸ‡­ Bahrain medical device regulatory data

Explore the medical device requirements currently available for Bahrain, organized by topic and linked to official sources.

35 facts23 dimensions14 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Prior authorisation required to market or advertise a medical device

advertising.prior-authorisation-required
Fact-level verified

Under Article (10) of Resolution No. (48) of 2020 as amended by Resolution No. (69) of 2024, except for low-risk home-use medical devices, no person may market or advertise a medical device or product without prior authorisation from NHRA and payment of the prescribed fees. NHRA regulates advertising through its Advertising Guideline and an advertising application form.

Conditions
  • The original Article (10) also provided that the advertising licence is cancelled if any pre-approved advertising content is changed
  • Low-risk home-use devices and products (digital thermometers, blood pressure monitors) are exempt from the prior-authorisation requirement

Verbatim source passage (pre-amendment text): "It is forbidden for any person to market or advertise the medical device and product unless obtaining a license from the Authority." The 2024 replacement reads: "Except for low-risk home-use medical devices and products, no person may market or advertise a medical device or product without obtaining prior authorization from the Authority and paying the prescribed fees."

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Marketing authorisation valid for three years under the 2024 amendment

renewal.marketing-authorisation-three-years
Fact-level verified

Resolution No. (69) of 2024 replaced the first two paragraphs of Article (10) of Resolution No. (48) of 2020 so that, except for low-risk home-use devices, no person may market or advertise a medical device without prior authorisation and payment of the prescribed fees, and the marketing authorisation for devices meeting global quality and safety standards is valid for three years after full payment of the fees. The earlier text set a twelve-month term or the expiry of the quality certificate, whichever was earlier.

Conditions
  • Low-risk home-use medical devices and products (for example digital thermometers and blood pressure monitors) are excluded from the prior-authorisation requirement
  • In force from the day following publication in Official Gazette No. 3781 of 21 November 2024
  • The registration guideline posted on the NHRA site has not yet been updated to reflect the three-year term

Effective from 2024-11-22

Verbatim source passage: "Except for low-risk home-use medical devices and products, no person may market or advertise a medical device or product without obtaining prior authorization from the Authority and paying the prescribed fees. The marketing authorization for medical devices and products that meet global quality and safety standards shall be valid for three years after the full payment of the prescribed fees."

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority: National Health Regulatory Authority (NHRA), Medical Devices & Supplies Control Section

authority.nhra-national-health-regulatory-authority
Fact-level verified

The competent authority for medical devices and IVDs in the Kingdom of Bahrain is the National Health Regulatory Authority (NHRA), established by Law No. (38) of 2009 as amended by Decree-Law No. (32) of 2015, acting through its Medical Devices & Supplies Control Section. NHRA licenses medical-device authorized representatives and facilities, classifies and registers devices, controls importation at the ports of entry through the OFOQ system, and operates post-market surveillance, field safety notice and recall functions. The Supreme Council of Health issues the governing resolutions.

Conditions
  • Resolution No. (48) of 2020 was issued by the Chairman of the Supreme Council of Health, not by NHRA directly
  • Article (14) of Resolution No. (48) of 2020 allows NHRA to delegate tasks to a Conformity Assessment Body while remaining responsible

Verbatim source passage (Article 4): "The Authority monitors the use of medical devices and products in the Kingdom and takes the necessary and appropriate measures to ensure the safety of their use and maintenance ... and the authority shall notify patients or users once it is confirmed that the medical device or product is/are not complying with the of the provisions of this decision."

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Minor variation approval; major variation requires a new registration application

change-control.minor-and-major-variation
Fact-level verified

Bahrain distinguishes minor variations, which do not affect safety or performance (renewal of any certificate or official letter, artwork or label changes, IFU changes, authorized-representative detail changes, device name or product identifier change, and adding devices to a licence for colour, package-quantity or volume variants, not applicable to IVDs), from major variations, which do affect safety or performance (change of legal or physical manufacturer or address, manufacturing process change, design or detailed specification change, risk-class change). A minor variation is approved by letter after review; a major variation requires a new registration application.

Conditions
  • NHRA must be informed instantly by email on receipt of a change notification from the manufacturer; NHRA review of a variation is 20 working days (Registration Guideline 9.1, section 9 'General directions')
  • Approval of the variation must be finalised before importation of the amended device
  • Price changes do not require a variation; the certificate validity does not change
  • Software: a variation is required for each new version; updates that affect the intended use are major

Registration Guideline 9.1, section 9, distinguishes minor changes from changes affecting safety or performance. Major variations require a new registration application. The guideline states a 20-working-day NHRA review period; the earlier 40-day transcription was incorrect.

Classification rules

What local class follows from which rules and decisive product facts?

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Four risk classes for devices (I, IIa, IIb, III) and four for IVDs (A, B, C, D)

classification.four-risk-classes
Fact-level verified

Bahrain classifies medical devices into four risk classes - class I low risk, class IIa low to medium risk, class IIb medium to high risk and class III high risk - and IVDs into class A (low individual and low public health risk), B (moderate individual and/or low public health risk), C (high individual and/or moderate public health risk) and D (high individual and high public health risk). Classification criteria must be fulfilled before submitting a registration application, and NHRA may require a classification letter for borderline products.

Conditions
  • Classification is a separate fee-bearing service with a review time of one to two weeks after fee payment
  • Classification letters relate to the submitted product only and do not cover other sizes or lots
  • A maximum of ten doses or sizes may be submitted in one classification application
  • Where a device is not manufactured in the EU, the guideline refers applicants to the EU classification rules (MDCG 2021-24)

Verbatim source passages: "I Low Risk Medical Device", "IIa Low to Medium risk device", "IIb Medium to High Risk Device", "III High Risk Device"; and for IVDs "A Low Individual Risk and Low Public Health Risk ... D High Individual Risk and High Public Health Risk".

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Current NHRA checklist: 16 documents for Phase II–III (all) and Phase IV (subset), including protocol, IB, ICF/CRF, insurance, investigator licences, IMPD/CMC, product labelling, GMP certificate, CRO authorisation, IREC approval and clinical trial agreement

clinical.application-document-checklist-2024
Fact-level verified

The 2024 checklist requires for Phase II–III: cover letter, application form, signed dated protocol, Investigator's Brochure, sample ICF and CRF, clinical trial insurance policy with corporate indemnity and malpractice clauses, CVs of investigators, sponsors, CROs and monitors, investigators' licences, IMPD or CMC, sample investigational product labelling and packaging, GMP certificate of the manufacturing facility, letter of authorisation to manufacture, certificate of analysis and quality, authorisation for a Bahrain-registered CRO, IREC approval letter and the clinical trial agreement. Phase IV applications omit the IB, insurance, IMPD/CMC, labelling, GMP, manufacturing authorisation and analysis certificates, but a Summary of Product Characteristics or Instructions for Use is required to show the product is used per its registration conditions.

Conditions
  • For a medical device the 'Instruction for use' alternative in footnote 1 is the applicable product document.
  • Labelling and packaging samples are required for Phase IV only when a randomised blinded design uses legally marketed products (footnote 2).

English source. Undated PDF whose file name carries '2024'; it supersedes the 21-item 'Clinical Trials Applications Requirement' list previously posted.

Every research involving humans needs IREC/NHRA ECPH ethics approval from each institution before any trial activity, and Phase II–III trials need an NHRA authorisation applied for at the NHRA CEO's office

clinical.ethics-committee-approval-before-any-trial-activity-and-nhra-authorisation
Fact-level verified

All research involving human beings must be reviewed by an Institutional Independent Research Ethics Committee (IREC) or, for private hospitals, the NHRA Ethics Committee for Private Hospitals, and sponsors must obtain such approval from each institution where the trial will run; local IRB/IREC approval letters are required before commencing any clinical trial or research activity in the Kingdom. For Phase II and III trials, the sponsor submits a cover letter and signed application form to the office of the NHRA Chief Executive Officer with two hard copies and one electronic copy of the package, organised in four parts (administrative; protocol and related documents; investigational product manufacturing and labelling; agreements, financial disclosures, investigator statement and proforma invoices).

Conditions
  • Phase I trials are stated as currently not authorised in Bahrain (page 6).
  • Phase IV trials go to the IREC first and then to NHRA for a no-objection letter (pages 10–12).
  • NHRA issues the import licence for the investigational product only after receiving the IREC/ECPH approval letter (page 8).

Effective from 2017-06-01

English source. The 2024 checklist footnote 3 restates: 'Local IRB/IREC letters of approval are required prior to commencing any clinical trial or research activities in the Kingdom.'

NHRA will withdraw or suspend a clinical trial authorisation, wholly or in part, if the sponsor or applicant fails to comply with any NHRA regulatory requirement

clinical.nhra-may-suspend-or-withdraw-authorisation-for-non-compliance
Fact-level verified

NHRA states that it will withdraw or suspend a clinical trial authorisation, as a whole or in part, if the sponsor and/or applicant fail to comply with any relevant NHRA regulatory requirement.

Conditions
  • Stated in the 2017 guide's Important Notes for both initial authorisations (page 9) and amendments (page 15).

Effective from 2017-06-01

English source.

A clinical trial is defined to include investigation of a medical device as investigational product; the NHRA regime therefore covers device clinical investigations

clinical.scope-covers-medical-device-investigational-products
Fact-level verified

The NHRA guide defines a clinical trial as any investigation or experiment in human subjects of an investigational product, expressly including medical devices, and defines an investigational product to include a medical device, a product already holding a marketing authorisation but used differently from the authorised form, or one used for unapproved indications.

Conditions
  • The regulatory requirements apply to all public and private healthcare facilities, healthcare providers, investigators, academic centres, sponsors and third parties participating in trials (page 5).
  • Phase terminology in the guide is drug-based; no device-specific (e.g. ISO 14155) pathway is described.

Effective from 2017-06-01

English source.

NHRA screens the application within 10 business days and either accepts it, issues a letter of deficiency placing it on hold, or refuses it; deficiencies must be addressed within 30 days before review starts

clinical.screening-deficiency-letter-and-30-day-cure-window
Fact-level verified

Within 10 business days of receipt NHRA, on the recommendation of its Clinical Trial Committee, either accepts the application and starts review, issues a letter of deficiency and puts the application on hold until the deficiencies are completed, or refuses it for incompleteness, an unqualified applicant or invalid documents. The applicant must address deficiencies within 30 days before review begins. NHRA then issues a no-objection or authorisation letter.

Conditions
  • Stated final-decision periods after acceptance are 45 days for international Phase III studies under an approved US IND or EU CTA, 60 days for international Phase II and non-US/EU Phase III trials, and 90 days for studies conducted only in Bahrain; recorded here as context, not as a review-clock fact.
  • The same screening and cure rules apply to substantial-amendment re-authorisations, with a 30-business-day screening period (page 13).

Effective from 2017-06-01

English source.

Substantial amendments to an approved trial need IREC approval and NHRA re-authorisation before implementation; minor amendments need only IREC confirmation, reported to NHRA with the annual progress report

clinical.substantial-amendments-need-irec-and-nhra-reauthorisation-minor-amendments-notified
Fact-level verified

No amendment to an approved protocol may be implemented without IREC/NHRA ECPH approval. NHRA treats any change that is not non-substantial as substantial, so the sponsor must await NHRA re-authorisation before implementing it, submitting a cover letter, summary of the amendment, list of modified documents with versions and dates, tracked changes, signatures and the IREC approval letter. Minor amendments may be implemented once the IREC confirms they are non-substantial, and that confirmation is submitted to NHRA with the yearly progress report.

Conditions
  • The trial may continue under the currently approved protocol while re-authorisation is pending (page 15, note b).

Effective from 2017-06-01

English source.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Statutory definition of medical device and IVD

scope.medical-device-and-ivd-definition
Fact-level verified

Resolution No. (48) of 2020 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment or alleviation of injury; investigation, replacement, modification or support of anatomy or a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; or providing information for medical or diagnostic purposes by in vitro examination of specimens from the human body - and which does not achieve its primary intended action by pharmacological, immunological or metabolic means. IVDs are separately defined as devices intended for in vitro examination of specimens derived from the human body to provide diagnostic, monitoring or compatibility information.

Conditions
  • The provisions apply to all facilities and to devices marketed in Bahrain, including contact lenses and laser devices used for non-surgical cosmetic purposes and their accessories
  • Accessories are defined as articles intended by the manufacturer to be used together with a particular device to enable or assist its use
  • Research-use-only products are not classified as medical devices and are not required to register

Verbatim source passage: "Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar or related article: A) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose (s) of: 1. diagnosis, prevention, monitoring, treatment, or alleviation of disease ... and B) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means."

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Registration dossier: unconditional and conditional document set

dossier.registration-requirement-set
Fact-level verified

The Bahraini registration dossier has seven unconditional items - technical details (IFU, leaflet or user manual), artwork/label, the manufacturer's authorization letter to the authorized representative, a relationship letter stating the link between legal and physical manufacturer and the invoice issuer, an ISO 13485 certificate for the physical manufacturer with verification evidence, a CE or FDA quality assurance certificate for the legal manufacturer with verification evidence, and an EU Declaration of Conformity carrying the GMDN code. Conditional items are the EC Design Examination certificate or FDA CFG for class III / class D IVD, a porcine-derivative-free statement for animal-tissue devices, and a classification letter for borderline products.

Conditions
  • Official letters and documents must be signed and stamped by the issuer; electronic signature and stamp are accepted
  • Purchasing and marketing prices entered in the registration form are confidential and used for study purposes only
  • NHRA may request additional documents as part of the review
  • Accessories and spare parts cannot be registered separately

Verbatim source passages: "1) Technical Details such as IFU, leaflet or user manual." and "5) Quality Management System Certificate (QMS) - ISO 13485 for the Physical manufacturer with the address matching requirement 4 along with verification evidence" and "7) Declaration of Conformity (DOC) as per EU regulations issued by the legal manufacturer. GMDN code can be included in the DOC or in a separate official letter."

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Foreign manufacturers must act through a Bahraini licensed authorized representative

operators.local-authorized-representative-required
Fact-level verified

Manufacturers outside Bahrain cannot apply directly: only a facility registered with NHRA as a Medical Device Authorized Representative may apply, import and hold the registration. Resolution No. (48) of 2020 Article (1) defines an authorized representative as a natural or legal person established within the Kingdom holding a written mandate from the manufacturer, and Article (6) as amended by Resolution No. (69) of 2024 requires all facilities to obtain a licence from the Authority and prohibits any activity related to medical devices except through a licensed facility.

Conditions
  • The AR registration certificate is valid for a minimum of one year and must be renewed six months before expiry
  • The AR must hold a commercial registration permitting medical device importation and an integrated system covering importation, marketing, transport, storage, recalls, complaints, adverse events, alerts and device tracing
  • The scope of devices is stated on the AR licence and chosen from an NHRA scope list
  • Transferring the local representative is treated as a minor variation of the device registration

Effective from 2024-11-22

Verbatim source passage: "All facilities must obtain a license from the Authority. It is prohibited to engage in any activity related to medical devices and products unless through a facility licensed by the Authority."

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Pre-approval of every shipment through the OFOQ customs system

establishment.import-preapproval-ofoq
Fact-level verified

Importation of medical devices into Bahrain requires NHRA pre-approval granted through the OFOQ system operated by Customs Affairs. All medical devices under HS-code ministry code 2251 must hold an online licence to clear customs, the request must be submitted before shipping, and importation must be carried out by an authorized representative from the legal manufacturer within its registered scope. Importation of used or refurbished devices is prohibited.

Conditions
  • Healthcare facilities may import only for their own use and within their scope of services
  • The AR must hold commercial registration activity 4659 (sale/trade in other machinery and equipment and parts - medical devices supplies and related parts)
  • Class II and III devices are those NHRA mostly regulates at import
  • Fee per importation approval: BHD 0.5 registered device / BHD 2 unregistered, per type (Resolution No. (24) of 2021)

Verbatim source passage: "Starting from 2016 all medical devices with the HS code listed under ministry code 2251 (NHRA medical devices) must hold an online license to be cleared by customs. All medical devices with HS codes regulated by NHRA must be granted with pre-approval by first submitting the required documents on OFOQ system." and "2- Importation of medical devices must be done through an authorized representative from the legal manufacturer."

Fees

What regulator fee applies to this class, route, event, and date?

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Updated NHRA fee schedule: BHD 150/300/1,000 registration or renewal per three-year licence

fees.medical-device-registration-and-facility-fees
Fact-level verified

NHRA Circular No. (15) of 2026, dated 9 June 2026, publishes the updated medical-device and supplies fee schedule applicable from 1 May 2026 unless NHRA instructs otherwise. Annex 1 Table 2 states that all medical-device registrations have a three-year validity: registration or renewal costs BHD 150 for low risk, BHD 300 for medium risk and BHD 1,000 for high risk, per three-year licence. The application submission fee is BHD 5 per application; the medical-device and supplies traceability fee is BHD 5 per individual device; updating device registration data costs BHD 20 per device.

Conditions
  • Amounts are in Bahraini dinar.
  • The current circular governs the listed services; facility licensing and importation have separate fees in Annex 1.

Effective from 2026-05-01

The official four-page scan was freshly retrieved. The registration table on page 3 and the effective-date and currency statements on page 4 were visually checked in the release review.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Label language: Arabic or English

label.arabic-or-english-permitted
Fact-level verified

Bahraini labelling rules require the label text to be clear and in Arabic or English, so English-only labelling is acceptable; Arabic is not mandatory. The label must carry the device name, manufacturer name and place, an identification number (catalogue, reference or model number), lot or serial number, date of manufacture, storage and handling conditions, sterile state and sterilisation method where applicable, warnings, single-use status, presence of medicinal substances, human blood or plasma derivatives, or tissues of human or animal origin, and an indication that the device is a medical device.

Conditions
  • The information must appear on the device itself where practicable, otherwise on the unit packaging or multi-unit packaging
  • Symbols to ISO 15223-1:2016 are permitted as an alternative to written language

Verbatim source passage: "4. Label font should be clear and in Arabic or English." This contradicts secondary consultancy summaries that describe Arabic labelling as mandatory in Bahrain.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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NHRA recommends a PMS officer; its authorized-representative guideline includes the assignment as a general rule

pms.authorized-representative-pms-officer
Fact-level verified

NHRA Circular No. (18) of 2022 (12 May 2022), issued with reference to Article (4) of Resolution No. (48) of 2020, states that it is 'strictly recommended' that all healthcare facilities and authorized representatives assign a post-market surveillance (PMS) officer responsible for handling medical device reporting in the post-market phase, including field safety notices, adverse events and complaints, and reporting them to NHRA. For authorized representatives the assignment is made a general rule by the Medical Device Authorized Representative Registration Guideline (Version 7.4, June 2023), general rule 5: 'The Authorized Representative should assign a PMS Officer for handling all safety issues related to the medical devices (reporting FSN, Adverse events, Complaints...etc) as per Circular No (18), 2022.'

Conditions
  • The nominated PMS officer's contact details must be sent to NHRA (via the QR code in the circular)
  • The AR must also maintain an integrated system for monitoring importation, marketing, transportation, storage, recalls, complaints, adverse events, alerts, modifications and tracing of distributed devices to end users (AR Registration Guideline 7.4, general rule 3)

Effective from 2022-05-12

Medical Devices Authorized Representative Registration Guideline, Version 7.4

Bilingual circular (Arabic and English). Verbatim English passage: "As a part of NHRA role to ensure the safety of medical devices in post market phase, it strictly recommended from all healthcare facilities and authorized representatives to assign a PMS officer who is responsible for handling medical devices reporting in the post market survalince stage including field safety notices, adverse events and complain reporting to NHRA ."

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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ISO 13485 certificate for the physical manufacturer, with verification evidence

qms.iso-13485-physical-manufacturer
Fact-level verified

The unconditional documentation set for Bahraini registration requires a Quality Management System certificate to ISO 13485 for the physical manufacturer, whose address must match the relationship letter, together with verification evidence. Certifying bodies issuing quality assurance certificates must be recognised by the EU for CE certificates and by IAF for ISO certificates.

Conditions
  • Manufacturer's Declaration of Conformity may substitute for a CE marking for class I products that lack CE
  • The AR facility itself is subject to an NHRA inspection before final approval, with a re-inspection fee of BHD 50 per request

Verbatim source passage: "12- All certifying bodies issuing the quality assurance certificate should be recognized by the EU for CE certificate and IAF for ISO certificate, kindly refer to Quality Assurance Certificates and Verification Process Guideline for more information." The ISO 13485 requirement itself is stated in Section 5 item 5 of the registration guideline, which was also retrieved and read.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Field safety notice must reach NHRA in 2, 5 or 10 working days by risk level

recall.fsn-notification-timeframes
Fact-level verified

When a field safety notice affects the Bahraini market, the authorized representative must provide a copy of the notice to NHRA within 2 working days for very high risk notices, 5 working days for high risk notices and 10 working days for moderate risk notices. The applicant then has one month from confirmation to supply the acknowledgment and evidence of action taken. Where the notice does not affect Bahrain, an official signed letter from the manufacturer confirming this must be provided.

Conditions
  • Evidence of action for a recall is either an invoice of destruction in Bahrain or an air way bill for return to the manufacturer
  • NHRA publishes the list of recalls and field safety corrective actions on its website
  • NHRA reviews the text and content of alerts with the manufacturer or authorized representative before issuing them

Verbatim source passage: "a copy of the notice must be provided to NHRA within: 2 working days in case of very high risk FSNs. 5 working days in case of high risk FSNs. 10 working days in case of moderate risk FSNs."

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Fast track through third-party services

pathways.fast-track-via-third-party
Fact-level verified

Bahrain operates an ordinary route through the Ajheza/Madar electronic system and a paid fast track delivered through third-party companies, with a shorter review clock (10 working days against 20). The device is registered by the same NHRA process in both cases.

Conditions
  • Fast track is provided through third-party service companies named in the 2025 SLA: Medspiro (Ψ΄Ψ±ΩƒΨ© Ω…ΩŠΨ―Ψ³Ψ¨ΩŠΨ±Ωˆ) and Adliya Business Center W.L.L. (Ψ΄Ψ±ΩƒΨ© ΨΉΨ―Ω„ΩŠΨ© Ψ¨Ψ²Ω†Ψ³ Ψ³Ω†ΨͺΨ± Ψ°.Ω….Ω…); the Authorized Representative Registration Guideline 7.4 names Adliya Business Center Co. W.L.L. (ABC) as the fast-track conformity assessment body for AR registration
  • Applications are submitted on Ajheza (per the guideline and SLA) or Madar (per the current service page)

Verbatim source passage: "The timeframe of registration application review is 20 working days. Fast track (Through third party services) is also available with a time frame of 10 working days."

Two-step route: device listing first, then registration, both through a licensed authorized representative

pathways.listing-before-registration
Fact-level verified

Only a registered authorized representative can apply for medical device registration in Bahrain. All devices that have been imported or are intended to be imported must first be listed with the medical devices section by submitting the listing sheet to medical_devices@nhra.bh; only listed devices can then be submitted for registration. Listing must be sent before the registration application and is not part of it.

Conditions
  • Registration is not linked to whether the HS code is regulated by NHRA or not
  • Devices must be registered by 30 April 2027 (classes IIa, IIb, III and IVD classes B, C, D) or 31 July 2027 (class I and IVD class A) under Circular No. (19) of 2026
  • All registered devices are published on the NHRA website together with their authorized representative

Verbatim source passage: "All registered medical devices authorized representatives (AR) must list all medical devices that have been imported or are intended to be imported in the future. Only listed medical devices can be applied for medical device registration. ... Listing should be submitted (including all medical devices) prior to submitting medical device registration applications and it should not be submitted as part of the medical device registration application."

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Bahrain approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Bahrain (8 records)

BahrainSaudi Arabia Β· US FDA Β· Australia TGA Β· Japan MHLW / PMDA Β· UK MHRA Β· Ireland Β· Swissmedic Β· France Β· Germany

Prior approval / evidence record

Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)

Authority

Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)

Accepted

Yes

Benefit

Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.

NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rules, process of submission, variation and renewalNHRA Medical Device Classification Guideline, Version 2.4 (June 2022) β€” important rules, classification review timeNHRA Medical Device Registration SLA 2025 β€” service completion time

Maintained reference Β· planning ranges remain estimates Β· reviewed 2026-09-16

BahrainUS FDA Β· Japan MHLW / PMDA Β· Saudi Arabia Β· Australia TGA Β· UK MHRA Β· Ireland Β· Swissmedic Β· France Β· Germany

Prior approval / evidence record

Registration certificate from a listed reference country is an alternative basis for Bahraini registration (Art. 7 bis)

reliance.reference-country-registration-certificate-route
Fact-level verified
Statement

Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment.

Source Approval

US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Only the nine authorities named in Article (7) bis are listed; Korea MFDS, Health Canada and China NMPA are not among them
  • The EU CE mark as such is not listed; the Union route appears only through three named national authorities (HPRA, ANSM, BfArM)
  • The application is still made by a Bahraini licensed Authorized Representative and the applicable fee must be paid
  • In force from the day following publication in the Official Gazette (No. 3781, 21 November 2024)
  • Resolution No. (69) of 2024 replaced Article (10) of Resolution No. (48) of 2020 so that marketing authorisation runs for three years

Effective from 2024-11-22

Verbatim source passage: "By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee."

BahrainEU conformity assessment Β· US FDA

Prior approval / evidence record

CE certificate under the medical-device directives/regulations or FDA Certificate to Foreign Government required as quality assurance certificate

reliance.ce-or-fda-quality-assurance-certificate
Fact-level verified
Statement

Registration of a medical device in Bahrain requires a Quality Assurance Certificate for the legal manufacturer, which is accepted in the form of a CE certificate under Directive 93/42/EEC, Regulation 2017/745, Directive 98/79/EC or Regulation 2017/746, or an FDA Certificate to Foreign Government (CFG), verified on the issuing body's website. The foreign approval is mandatory supporting paperwork for a local review that still runs in full, not a route that shortens it.

Source Approval

EU CE marking under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746; US FDA Certificate to Foreign Government (CFG)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Not applicable for class I non-sterile devices and Class A / other IVDs, for which a Declaration of Conformity may be accepted instead
  • The certificate must be verified on the issuing body's website (Quality Assurance Certificates and Verification Process Guideline)
  • The address on the certificate must match the artwork
  • Applies to the legal manufacturer; a separate ISO 13485 certificate is required for the physical manufacturer

Verbatim source passage: "Quality Assurance Certificate (QAC) - CE directives 93/42/EEC, 2017/745, 98/79/EC, 2017/746 or FDA Certificate to Foreign Government (CFG) for the Legal manufacturer with the address matching the artwork along with verification evidence ... Not applicable for class I non-sterile and Class A/others IVD."

BahrainEU conformity assessment Β· US FDA

Prior approval / evidence record

EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government

Authority

EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government

Accepted

Yes

Benefit

Mandatory supporting documentation for a local review that still runs in full, not a route that shortens it: the CE certificate or CFG is the Quality Assurance Certificate required for the legal manufacturer, and for class III and class D IVDs the EC Design Examination certificate or CFG is an additional class-specific dossier item.

NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rules, process of submission, variation and renewalNHRA Medical Device Classification Guideline, Version 2.4 (June 2022) β€” important rules, classification review timeNHRA Medical Device Registration SLA 2025 β€” service completion time

Maintained reference Β· planning ranges remain estimates Β· reviewed 2026-09-16

BahrainSaudi Arabia Β· US FDA Β· UK MHRA Β· Australia TGA Β· Health Canada Β· Japan MHLW / PMDA Β· Swissmedic Β· Ireland Β· Denmark Β· New Zealand Β· France Β· Netherlands Β· Belgium

Prior approval / evidence record

Free Sale Certificate may be issued by the country of origin or by a reference country

reliance.free-sale-certificate-origin-or-reference-country
Fact-level verified
Statement

At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).

Source Approval

Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The classification guideline separately accepts a Free Sale Certificate OR Registration Certificate from one of the reference countries as a classification requirement
  • The reference-country list in the registration guideline glossary includes Canada, Denmark, the Netherlands ('Holland') and New Zealand, which are not in the Article (7) bis list of Resolution No. (69) of 2024, and omits Germany
  • Free Sale Certificate is also required on manufacturer acquisition (Section 12)

Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."

BahrainSource authority not specified

Prior approval / evidence record

GCC central registration issued by the Gulf Health Council, or GSO/G-mark conformity

Authority

GCC central registration issued by the Gulf Health Council, or GSO/G-mark conformity

Accepted

No

Benefit

There is no GCC device mutual recognition reaching Bahrain. Resolution No. (85) of 2023 simply adopts the Gulf standard specifications for the health sector issued by the GCC Standardization Organization as Bahraini national standards, which is standard harmonisation; the only way another GCC member's registration helps is through the Article (7) bis route, in which SFDA happens to be one of the nine named authorities.

NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rules, process of submission, variation and renewalNHRA Medical Device Classification Guideline, Version 2.4 (June 2022) β€” important rules, classification review timeNHRA Medical Device Registration SLA 2025 β€” service completion time

Maintained reference Β· planning ranges remain estimates Β· reviewed 2026-09-16

BahrainSaudi Arabia Β· US FDA Β· UK MHRA Β· Australia TGA Β· Health Canada Β· Japan MHLW / PMDA Β· Swissmedic Β· Ireland Β· Denmark Β· New Zealand Β· France Β· Netherlands Β· Belgium

Prior approval / evidence record

Classification of a product as a medical device may be evidenced by a registration certificate from a reference country

reliance.reference-country-certificate-for-classification
Fact-level verified
Statement

To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.

Source Approval

Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

classification

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • A classification letter is a separate, fee-bearing NHRA service that precedes importation and registration
  • The reference-country list here is broader than the Article (7) bis list in Resolution No. (69) of 2024 and omits Germany and includes Canada, Denmark, the Netherlands and New Zealand
  • For class I products without CE marking a manufacturer's Declaration of Conformity may be provided

Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."

BahrainEU conformity assessment Β· US FDA

Prior approval / evidence record

Class III / Class D IVD requires an EC Design Examination certificate or FDA Certificate to Foreign Government

reliance.class-iii-ec-design-examination-or-fda-cfg
Fact-level verified
Statement

For class III medical devices and class D IVDs, Bahrain requires an EC Design Examination certificate or an FDA Certificate to Foreign Government for the legal manufacturer; the same document must be supplied for class IIb devices if available. The named foreign instrument is a mandatory class-specific dossier item, not a shortened review.

Source Approval

EC Design Examination certificate (EU notified body); US FDA Certificate to Foreign Government (CFG)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Also required for class IIb medical devices 'if available'
  • Verification evidence for the EC Design Examination certificate must be provided
  • Class mapping: Bahrain classes I, IIa, IIb, III for general devices; classes A-D for IVDs

Verbatim source passage: "For class III medical devices as well as class D IVD's, an EC Design examination certificate or an FDA Certificate to Foreign Government (CFG) for the legal manufacturer is required along with verification evidence ... This document needs to be submitted for class IIB medical devices if available."

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Registration and variation review: 20 working days; fast track: 10 working days; classification: 1–2 weeks

review-clocks.registration-20-working-days
Fact-level verified

NHRA Registration Guideline 9.1, section 2 item 11, gives a 20-working-day registration review period and a 10-working-day fast track through third-party services. Section 9 gives a 20-working-day variation review period. Classification Guideline 2.4, Important Rules (page 3), gives one to two weeks for reviewing submitted documents after fee payment.

Conditions
  • These are the published guideline service periods; NHRA may request additional documents.
Medical Device Classification Guideline, Ref. 2022-MDGUD-Q2-011, Version 2.4, June 2022

Both official guideline PDFs were freshly retrieved and the cited service periods re-read in the release review. The claim is confined to the published review periods, excluding any inference about import permission before registration.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Cases exempt from medical device registration

special-access.registration-exemptions
Fact-level verified

Circular No. (1) of 2022, issued under Resolution No. (48) of 2020, exempts from registration: devices imported for a healthcare facility for an emergency or on a single occasion and not planned for regular importation; devices imported for research and educational purposes; personal imported devices; custom-made devices or orders for a specific patient; and samples for exhibitions and conferences. Authorized-representative warehouses already licensed by the pharmaceutical products regulation section are also exempt from facility registration.

Conditions
  • The circular states these devices 'will not be subjected to registration' rather than being subject to a lighter route
  • NHRA also publishes a list of medical devices approved for emergency use
  • Article (8) of Resolution No. (48) of 2020 requires health facilities to obtain a permit to use devices before using them

Effective from 2022-01-19

Bilingual circular. Verbatim English passage: "Based on the resolution no (48) for the year of 2020, NHRA would like to clarify that the following medical devices will not be subjected to registration: 1 Medical device imported for healthcare facilities for: Emergency; A single time and not planned to be imported on a regular basis. 2 Medical devices imported for research and educational purposes. 3 Personal imported medical devices. 4 Custom-made medical devices or order for specific patient. 5 Samples for exhibition and conferences."

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Two further submission attempts without repaying the fee; 10 working days to appeal a rejection

submission.resubmission-attempts-and-appeal
Fact-level verified

If a Bahraini registration application does not fulfil all requirements it is returned with the recommended action; the applicant has two further submission attempts without repaying the application fee, and if the third submission still fails the application is rejected and the fee must be paid again. Where a rejection or return can be justified without new documents, the applicant has 10 working days to submit an appeal with justification. Classification requests likewise allow up to three resubmissions before a new fee is due.

Conditions
  • Each resubmission requires booking a new appointment in the Ajheza system
  • Classification review time after fee payment is one to two weeks

Verbatim source passage: "applicants have 10 working days to submit for appeal and provide justification."

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Authorized representative must list all devices before applying for registration

udi.authorized-representative-must-list-all-devices
Fact-level verified

Every registered authorized representative must list all medical devices that have been imported or are intended to be imported in the future. Only listed medical devices can be applied for registration. The listing must be submitted before the registration applications, and must not be submitted as part of a registration application.

Source is the NHRA's own registration guideline, in English. The listing sheet referenced by the section is published by NHRA as MDR_Form_Medical devices listing.xlsx; submission is by e-mail to medical_devices@nhra.bh. Section 2(1) of the same guideline adds that only a registered authorized representative may apply for medical device registration.

Statutory electronic registration system recording device identification, origin and shelf life

udi.electronic-registration-system-records-device-data
Fact-level verified

The Authority establishes an electronic system for the registration of medical devices and products and of the facilities dealing in them, in which all data relating to the device and the establishment are recorded β€” in particular the name of the device, its serial number, its country of origin and its shelf life. The system also carries the information required to register devices and facilities, a view of market size, information on facilities that manufacture, distribute or import devices in the Kingdom, and information on devices that will be marketed or are already in use there. Resolution 48/2020 separately defines a 'Medical Devices and Products Record' as a database of medical devices and products and the facilities used for them.

NHRA publishes the English text of Resolution 48/2020. Article 5 establishes the device/establishment record; it does not itself establish a UDI issuance duty.

Written Authority approval required to transfer, resell, dispose of or export a device

udi.transfer-resale-disposal-export-need-written-approval
Fact-level verified

Article (7) of Resolution No. (48) of 2020, as replaced by Resolution No. (69) of 2024, provides that medical devices and products must be used in health facilities licensed by the Authority; that it is prohibited to manufacture, import or introduce any medical device or product into the Kingdom, market it or use it unless it has been registered with the Authority and a written marketing authorization has been obtained; and that it is prohibited to transport, store, resell, dispose of or export such devices or products without written approval from the Authority. The original 2020 text covered transfer, resale, disposal and export; the 2024 replacement adds import, transport and storage. Article (13) adds that facilities must dispose of devices in accordance with the requirements and that devices may not be used beyond their shelf life.

English text published by NHRA; quoted verbatim. Art. 13 of the same resolution adds, subject to Art. 7, that facilities must dispose of devices in accordance with the requirements and that devices may not be used beyond their shelf life.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Adverse event reporting: 10 working days for death or serious injury, 30 working days otherwise

vigilance.adverse-event-reporting-timeframes
Fact-level verified

Adverse events associated with a medical device are reported to NHRA on the Medical Devices Reporting form. Death or serious injury must be reported within 10 working days and other problems not associated with high risk or injury within 30 working days, by manufacturers, authorized representatives/suppliers and healthcare facilities alike; reports must be submitted immediately and fully. NHRA reviews reports, may request further information and may consult other authorities.

Conditions
  • Reportable events are those that led or could have led to death or serious deterioration in health, where the device contributed or may have contributed
  • Non-reportable events are listed in the guideline

Verbatim source passage (table): "Death / Serious injury | NHRA | 10 working days. | Other Problems not associated with high risk or injury. | NHRA | 30 working days."

Related structured datasets

Classification systems Β· 2 records
Open Bahrain IVD classes A, B, C and D β†’
Id

bahrain:ivd

Jurisdiction Id

bahrain

Domains
  • ivd
Name

Bahrain IVD classes A, B, C and D

Description

Bahrain classifies in-vitro diagnostic medical devices on a separate four-band axis published in the same section of the NHRA Medical Device Classification Guideline: class A low individual risk and low public health risk, class B moderate individual risk and/or low public health risk, class C high individual risk and/or moderate public health risk, and class D high individual risk and high public health risk. IVD classes B, C and D must be registered; class A registration is optional (Registration Guideline Version 9.1, general rule 2).

Classes
  • Id

    a

    Label

    Class A β€” Low Individual Risk and Low Public Health Risk

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B β€” Moderate Individual Risk and/or Low Public Health Risk

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C β€” High Individual Risk and/or Moderate Public Health Risk

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D β€” High Individual Risk and High Public Health Risk

    Normalized Risk Level

    highest

Regulator

NHRA

Official Domains
  • nhra.bh
Source Status

official-source-verified

Reference Sources
  • Title

    NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rule 2, which classes must be registered

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%209.1.pdf

    Reviewed On

    2026-09-16

    Supports

    General rule 2 makes registration mandatory for class IIa, IIb and III devices and IVD classes B, C and D, and optional for low-risk devices β€” the national delta that turns the IVD class axis into an obligation.

Source Title

NHRA Medical Device Classification Guideline, Version 2.4 (June 2022) β€” section 4, in-vitro diagnostic device class table

Source Url

https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Devices%20Classification%20Guideline%20Ver%202.4%2029%20June%202022.pdf

Verified On

2026-09-16

Source Supports
  • ivd-class-axis
Open Bahrain classes I, IIa, IIb and III β€” four-band device axis β†’
Id

bahrain:medical-device

Jurisdiction Id

bahrain

Domains
  • medical-device
Name

Bahrain classes I, IIa, IIb and III β€” four-band device axis

Description

Bahrain classifies medical devices into four risk classes on the axis published in section 4 of the NHRA Medical Device Classification Guideline (Version 2.4, June 2022): class I low risk, class IIa low to medium risk, class IIb medium to high risk and class III high risk. The classification letter that fixes the class is a separate, fee-bearing NHRA service; the guideline states that the class is determined by the manufacturer and that where a device is not manufactured in the EU the applicant is referred to the EU classification rules (MDCG 2021-24).

Classes
  • Id

    i

    Label

    Class I β€” Low Risk Medical Device

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa β€” Low to Medium risk device

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb β€” Medium to High Risk Device

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III β€” High Risk Device

    Normalized Risk Level

    highest

Regulator

NHRA

Official Domains
  • nhra.bh
  • ec.europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    MDCG 2021-24, Guidance on classification of medical devices β€” the EU rules the NHRA guideline refers applicants to for devices not manufactured in the EU

    Url

    https://ec.europa.eu/health/system/files/2021-10/mdcg_2021-24_en_0.pdf

    Reviewed On

    2026-09-16

    Supports

    The NHRA guideline prints this URL verbatim under its class tables ('In case of importing medical devices NOT manufactured in EU, please refer to below link for more information about classification rules of medical devices based on level of risk'). It is the only rule set Bahrain's classification guideline points to as the substantive classifier, so it is carried as the national overlay's rule reference; the four-class axis itself is Bahrain's own and comes from the guideline, not from MDCG 2021-24.

Source Title

NHRA Medical Device Classification Guideline, Version 2.4 (June 2022), Ref. 2022-MDGUD-Q2-011 β€” section 4 'Classification based on level of risk'

Source Url

https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Devices%20Classification%20Guideline%20Ver%202.4%2029%20June%202022.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning Β· 1 record
Open Bahrain registration β†’
Country

Bahrain

Jurisdiction Id

bahrain

Country Code

BH

Flag

πŸ‡§πŸ‡­

Regulator

National Health Regulatory Authority

Regulator Abbrev

NHRA

Region

middle-east

Tier

3

Risk Classification

4-class device axis (I, IIa, IIb, III) and separate 4-class IVD axis (A, B, C, D) β€” NHRA Medical Device Classification Guideline Ver 2.4

Classes
  • Id

    registration-standard-review

    Class Name

    Medical device registration β€” standard NHRA review

    Pathway

    Application filed by a registered Bahrain Authorized Representative: the device is listed with NHRA, an appointment is booked in the Ajheza system, and the full dossier is submitted at the appointment

    Official Timeline
    Min

    20

    Max

    20

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rules, process of submission, variation and renewal

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%209.1.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    3

    Notes
    • Registration Guideline Version 9.1, general rule 11: 'The timeframe of registration application review is 20 working days.' Section 3 repeats it: 'The review process timeframe is 20 working days.'
    • This is the registration review clock and not the classification clock: the classification letter is a separate fee-bearing service on its own clock.
    • The same 20 working days is granted for all classes that must be registered (IIa, IIb and III; IVD B, C and D), so the clock is a property of the route rather than of the risk class.
    • An application that does not fulfil all requirements is returned with the recommended action; the applicant has two further submission attempts without repaying the application fee, and rejection on the third attempt requires the fee to be paid again.
    • The 2025 SLA states the same figure of 20 working days for the registration service.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    registration-fast-track

    Class Name

    Medical device registration β€” fast track through third-party services

    Pathway

    Registration application routed through a third-party service provider

    Official Timeline
    Min

    10

    Max

    10

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rules, process of submission, variation and renewal

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%209.1.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • Registration Guideline Version 9.1, general rule 11: 'Fast track (Through third party services) is also available with a time frame of 10 working days.'
    • The 2025 SLA carries the same fast-track figure. The guideline does not restrict the fast track by risk class, so the clock is a property of the route.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    product-classification-request

    Class Name

    Product classification request β€” NHRA classification letter

    Pathway

    Application for a classification letter, submitted with the free sale certificate or registration certificate from the country of origin or a reference country and a recognised quality assurance certificate

    Official Timeline
    Min

    1

    Max

    2

    Unit

    weeks

    Verification Status

    official-verified

    Official Source
    Title

    NHRA Medical Device Classification Guideline, Version 2.4 (June 2022) β€” important rules, classification review time

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Devices%20Classification%20Guideline%20Ver%202.4%2029%20June%202022.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    6

    Unit

    weeks

    Notes
    • Classification Guideline Version 2.4, section 2: 'Timeline for reviewing the submitted documents after fees payment is 1 to 2 weeks.'
    • The clock runs from payment, and the guideline warns that classification is not accepted for products with different intended uses in one application (up to 10 doses or sizes), and that three failed submissions make the request a new fee-bearing request.
    • The letter relates to the submitted product only and does not cover other sizes or lot numbers, and it must be obtained before importation and before registration.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    minor-variation-review

    Class Name

    Minor variation review

    Pathway

    Variation application on the NHRA variation form, filed when the change does not affect the safety or performance of the device

    Official Timeline
    Min

    20

    Max

    20

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rules, process of submission, variation and renewal

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%209.1.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • Registration Guideline Version 9.1, section 9 general directions: 'Timeframe of NHRA review is 20 working days.'
    • The applicant must inform NHRA instantly by email on receiving a change notification from the manufacturer; the variation must be approved before the amended device is imported.
    • A change in risk classification, in the legal or physical manufacturer or address, or in the manufacturing process is a major variation and requires a new registration application, not this clock.
    • This is the figure printed in the guideline currently served by NHRA. The round-204 reliance research recorded 40 working days for the variation clock with a quotation that does not appear in Version 9.1 β€” the string '40' does not occur anywhere in the served PDF. See unresolved.variationClock.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)

    Accepted

    Yes

    Benefit

    Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.

  • Authority

    EU CE certificate under MDD 93/42/EEC, MDR 2017/745, IVDD 98/79/EC or IVDR 2017/746, or US FDA Certificate to Foreign Government

    Accepted

    Yes

    Benefit

    Mandatory supporting documentation for a local review that still runs in full, not a route that shortens it: the CE certificate or CFG is the Quality Assurance Certificate required for the legal manufacturer, and for class III and class D IVDs the EC Design Examination certificate or CFG is an additional class-specific dossier item.

  • Authority

    GCC central registration issued by the Gulf Health Council, or GSO/G-mark conformity

    Accepted

    No

    Benefit

    There is no GCC device mutual recognition reaching Bahrain. Resolution No. (85) of 2023 simply adopts the Gulf standard specifications for the health sector issued by the GCC Standardization Organization as Bahraini national standards, which is standard harmonisation; the only way another GCC member's registration helps is through the Article (7) bis route, in which SFDA happens to be one of the nine named authorities.

Key Requirements
  • Only a facility licensed by NHRA as a Medical Device Authorized Representative may apply for, hold and renew a device registration; a manufacturer outside Bahrain cannot apply directly.
  • Registration is mandatory for class IIa, IIb and III medical devices and for IVD classes B, C and D; registration of class I and IVD class A devices is optional.
  • Every device intended for import must first be listed with NHRA on the medical devices listing sheet, which must not be submitted as part of the registration application.
  • The dossier carries seven unconditional items including technical details (IFU, leaflet or user manual), artwork or label, the manufacturer's authorisation, and a Declaration of Conformity issued by the legal manufacturer; all official letters and documents must be signed and stamped by the issuer, with electronic signature and stamp accepted.
  • Class III devices and class D IVDs must add an EC Design Examination certificate or an FDA Certificate to Foreign Government; class IIb devices must add one if available.
  • The Quality Assurance Certificate is required for the legal manufacturer, must be verified on the issuing body's website and its address must match the artwork; a separate ISO 13485 certificate is required for the physical manufacturer.
  • Accessories and spare parts cannot be registered separately; on importation the applicant must provide evidence from the legal manufacturer that the item is an accessory or spare part of a registered device.
  • A registration application that does not meet all requirements is returned with two further submission attempts without repaying the application fee; a third failure is rejected and the fee must be paid again to resubmit.
  • Appeals against a rejection must be submitted with justification within 10 working days.
  • Imports require an OFOQ pre-approval filed with Customs Affairs before the shipment is dispatched, and the device must be imported in a form identical to the approved type.
  • A device with a radio interface additionally requires a TRA type approval certificate before it may be supplied, imported or distributed, and CE-marked private-use equipment without radiocommunications interfaces is the only published exemption.
  • Radiation-emitting devices additionally require an SCE approval to use ionizing radiation sources, applied for per model and serial number in the Environmental Licensing System.
Local Rep Required

Yes

Local Rep Name

Bahrain Authorized Representative (AR) β€” a facility licensed by NHRA

Mdsap Accepted

No

Mdsap Benefit

No MDSAP route is published. NHRA accepts an ISO 13485 certificate or a CE / FDA quality-assurance certificate as the QMS evidence, and requires a Declaration of Conformity from the legal manufacturer.

Registration Validity

Three years: Article (10) of Resolution No. (48) of 2020, as replaced by Resolution No. (69) of 2024, provides that the marketing authorization for devices meeting global quality and safety standards is valid for three years after full payment of the prescribed fees, and Circular No. (15) of 2026 confirms that all medical device registrations have a 3-year validity period. Registration Guideline Version 9.1 still prints a one-year validity β€” see unresolved.registrationValidity.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    NHRA Medical Devices Registration Guideline, Version 9.1 (September 2024) β€” general rules, process of submission, variation and renewal

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%209.1.pdf

    Accessed Date

    2026-09-16

  • Title

    NHRA Medical Device Classification Guideline, Version 2.4 (June 2022) β€” important rules, classification review time

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Devices%20Classification%20Guideline%20Ver%202.4%2029%20June%202022.pdf

    Accessed Date

    2026-09-16

  • Title

    NHRA Medical Device Registration SLA 2025 β€” service completion time

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Device%20Registration%20SLA_2025.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by NHRA. Appoint a Bahrain Authorized Representative (AR) β€” a facility licensed by NHRA.

    Duration

    1-3 months

    Icon

    πŸ“‹

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to NHRA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    πŸ“€

  • Step

    3

    Title

    Administrative Review

    Description

    NHRA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    πŸ”

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. NHRA may issue questions.

    Duration

    20 working days

    Icon

    βš™οΈ

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, NHRA issues Bahrain market authorization certificate.

    Duration

    1-2 weeks

    Icon

    βœ…

Government fee schedules Β· 1 record
Open Bahrain fees β†’
Jurisdiction Id

bahrain

Country

Bahrain

Country Code

BH

Authority

NHRA

Low Risk Local
Min

150

Max

150

Currency

BHD

Per Product

No

High Risk Local
Min

1000

Max

1000

Currency

BHD

Per Product

No

Details
  • Id

    medical-device-registration-application

    Item

    Application to submit a medical device registration

    Currency

    BHD

    Amount Local

    5

    Amount Local Formatted

    BHD 5

    Frequency

    Each application

    Notes

    Table 2. Charged in addition to the risk-based registration or renewal fee below.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    traceability-fee-per-device

    Item

    Medical Device & Supplies traceability fee

    Currency

    BHD

    Amount Local

    5

    Amount Local Formatted

    BHD 5

    Frequency

    Each individual device

    Notes

    Table 2. This line does not appear in Resolution No. (24) of 2021 and is new in Circular No. (15) of 2026; it is charged per individual device, not per model.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    low-risk-registration-or-renewal

    Item

    Low risk medical device registration or renewal

    Currency

    BHD

    Amount Local

    150

    Amount Local Formatted

    BHD 150

    Frequency

    Every 3 years per licence

    Notes

    Table 2, norm column 'Triannual per license'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    medium-risk-registration-or-renewal

    Item

    Medium risk medical device registration or renewal

    Currency

    BHD

    Amount Local

    300

    Amount Local Formatted

    BHD 300

    Frequency

    Every 3 years per licence

    Notes

    Table 2, norm column 'Triannual per license'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    high-risk-registration-or-renewal

    Item

    High risk medical device registration or renewal

    Currency

    BHD

    Amount Local

    1000

    Amount Local Formatted

    BHD 1,000

    Frequency

    Every 3 years per licence

    Notes

    Table 2, norm column 'Triannual per license'. This is the highest device-registration fee in the schedule.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    update-registration-data

    Item

    Update medical device registration data

    Currency

    BHD

    Amount Local

    20

    Amount Local Formatted

    BHD 20

    Frequency

    Each device

    Notes

    Table 2.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-application

    Item

    Authorized Representative licence application fee

    Currency

    BHD

    Amount Local

    50

    Amount Local Formatted

    BHD 50

    Frequency

    Each new order

    Notes

    Table 1. Only a facility licensed by NHRA as a Medical Device Authorized Representative may hold a device registration, so this licence is a precondition of every registration.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-a-first

    Item

    Authorized Representative licence, Class A β€” first licence

    Currency

    BHD

    Amount Local

    1000

    Amount Local Formatted

    BHD 1,000

    Frequency

    First licence

    Notes

    Table 1. The class-licence fee decreases as the class number rises, as printed.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-a-renewal

    Item

    Authorized Representative licence, Class A β€” renewal

    Currency

    BHD

    Amount Local

    700

    Amount Local Formatted

    BHD 700

    Frequency

    Annual

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-b-first

    Item

    Authorized Representative licence, Class B β€” first licence

    Currency

    BHD

    Amount Local

    700

    Amount Local Formatted

    BHD 700

    Frequency

    First licence

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-b-renewal

    Item

    Authorized Representative licence, Class B β€” renewal

    Currency

    BHD

    Amount Local

    500

    Amount Local Formatted

    BHD 500

    Frequency

    Annual

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-c-first

    Item

    Authorized Representative licence, Class C β€” first licence

    Currency

    BHD

    Amount Local

    500

    Amount Local Formatted

    BHD 500

    Frequency

    First licence

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-c-renewal

    Item

    Authorized Representative licence, Class C β€” renewal

    Currency

    BHD

    Amount Local

    300

    Amount Local Formatted

    BHD 300

    Frequency

    Annual

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-d-first

    Item

    Authorized Representative licence, Class D β€” first licence

    Currency

    BHD

    Amount Local

    300

    Amount Local Formatted

    BHD 300

    Frequency

    First licence

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    authorized-representative-licence-class-d-renewal

    Item

    Authorized Representative licence, Class D β€” renewal

    Currency

    BHD

    Amount Local

    200

    Amount Local Formatted

    BHD 200

    Frequency

    Annual

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    warehouse-licence-first

    Item

    Medical devices warehouse licensing β€” first licence

    Currency

    BHD

    Amount Local

    1000

    Amount Local Formatted

    BHD 1,000

    Frequency

    First licence

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    warehouse-licence-renewal

    Item

    Medical devices warehouse licensing β€” renewal

    Currency

    BHD

    Amount Local

    800

    Amount Local Formatted

    BHD 800

    Frequency

    Annual

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    manufacturer-licence-first

    Item

    Medical devices manufacturer licensing β€” first licence

    Currency

    BHD

    Amount Local

    5000

    Amount Local Formatted

    BHD 5,000

    Frequency

    First licence

    Notes

    Table 1. Applies to a local manufacturing site licensed by NHRA, not to the foreign legal manufacturer.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    manufacturer-licence-renewal

    Item

    Medical devices manufacturer licensing β€” renewal

    Currency

    BHD

    Amount Local

    3000

    Amount Local Formatted

    BHD 3,000

    Frequency

    Annual

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    update-facility-data

    Item

    Update medical device facilities data

    Currency

    BHD

    Amount Local

    50

    Amount Local Formatted

    BHD 50

    Frequency

    Each request

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    facility-re-inspection

    Item

    Re-inspection of medical device facilities

    Currency

    BHD

    Amount Local

    50

    Amount Local Formatted

    BHD 50

    Frequency

    Each request

    Notes

    Table 1.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    import-approval-medical-device-registered

    Item

    Request approval to import a single registered medical device

    Currency

    BHD

    Amount Local

    0.5

    Amount Local Formatted

    BHD 0.500

    Frequency

    Each type

    Notes

    Table 3. Bahraini Dinar is a three-decimal currency; the annex prints this as 0.5.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    import-approval-medical-device-unregistered

    Item

    Request approval to import a single unregistered medical device

    Currency

    BHD

    Amount Local

    2

    Amount Local Formatted

    BHD 2

    Frequency

    Each type

    Notes

    Table 3. Four times the registered-device rate.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    import-approval-ivd-registered

    Item

    Request approval to import a single registered IVD or combined medical device

    Currency

    BHD

    Amount Local

    1

    Amount Local Formatted

    BHD 1

    Frequency

    Each type

    Notes

    Table 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    import-approval-ivd-unregistered

    Item

    Request approval to import a single unregistered IVD or combined medical device

    Currency

    BHD

    Amount Local

    3

    Amount Local Formatted

    BHD 3

    Frequency

    Each type

    Notes

    Table 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    quality-certificate-validity-verification

    Item

    Verify the validity of the quality certificate

    Currency

    BHD

    Amount Local

    5

    Amount Local Formatted

    BHD 5

    Frequency

    Each type

    Notes

    Table 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    product-classification-request-regular

    Item

    Product classification request β€” regular

    Currency

    BHD

    Amount Local

    20

    Amount Local Formatted

    BHD 20

    Frequency

    Each type

    Notes

    Table 3. The classification letter is a precondition of importation and of registration.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    product-classification-request-urgent

    Item

    Product classification request β€” urgent

    Currency

    BHD

    Amount Local

    40

    Amount Local Formatted

    BHD 40

    Frequency

    Each type

    Notes

    Table 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    import-demurrage

    Item

    Demurrage for the device until approval

    Currency

    BHD

    Amount Local

    100

    Amount Local Formatted

    BHD 100

    Frequency

    Per day per shipment

    Notes

    Table 3. Charged while a shipment waits for approval, which is why the importation guideline requires the OFOQ request to be filed before shipping.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    product-classification-certificate

    Item

    Issuing a product classification certificate

    Currency

    BHD

    Amount Local

    15

    Amount Local Formatted

    BHD 15

    Frequency

    Each certificate

    Notes

    Table 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    sample-examination

    Item

    Sample examination

    Currency

    BHD

    Amount Local

    5

    Amount Local Formatted

    BHD 5

    Frequency

    Each type

    Notes

    Table 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    port-shipment-inspection

    Item

    Inspecting the shipment at the port

    Currency

    BHD

    Amount Local

    10

    Amount Local Formatted

    BHD 10

    Frequency

    Each type

    Notes

    Table 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    permit-to-use-device

    Item

    Submit a request for approval to use the device β€” permit to use device

    Currency

    BHD

    Amount Local

    0.5

    Amount Local Formatted

    BHD 0.500

    Frequency

    Each device

    Notes

    Table 4.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    evaluate-product-viability

    Item

    Evaluate the viability of the product

    Currency

    BHD

    Amount Local

    50

    Amount Local Formatted

    BHD 50

    Frequency

    Each device

    Notes

    Table 4.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    issuing-certificates

    Item

    Issuing certificates for medical manufacturer and devices, free sale and other paper documents

    Currency

    BHD

    Amount Local

    10

    Amount Local Formatted

    BHD 10

    Frequency

    Each request

    Notes

    Table 4.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

  • Id

    product-disposal-supervising

    Item

    Product disposal supervising

    Currency

    BHD

    Amount Local

    25

    Amount Local Formatted

    BHD 25

    Frequency

    Each request

    Notes

    Table 4.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Source Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Source Effective Date

    2026-05-01

    Verified On

    2026-09-16

Notes
  • Circular No. (15) of 2026 is dated 9 June 2026 and states that the schedule 'shall be applied from 1 May 2026, unless otherwise instructed by NHRA'; it is issued in reference to Resolution No. (24) of 2021, which amended Resolution No. (20) of 2016 on the categories of fees for private healthcare facilities, and in accordance with Resolution No. (48) of 2020 on the control of the quality of medical devices and products.
  • The circular is a scanned annex with no text layer; every amount here was read from the page images and cross-checked across two OCR passes. All fees are stated in Bahraini Dinar.
  • Table 2 states in terms that 'All medical device registrations have a 3-year validity period', which is consistent with the three-year marketing authorisation introduced by Resolution No. (69) of 2024 and inconsistent with the one-year validity still printed in Registration Guideline Version 9.1 β€” see unresolved.registrationValidity.
  • The risk-based registration fee is charged per licence for a three-year period, not per product or per application: the BHD 5 application fee and the BHD 5 per-device traceability fee are separate lines.
  • The Medical Device Registration SLA 2025 still cites its fee column to 'the table in (b) of the Minister of Health's Resolution No. (24) of 2021'; Circular No. (15) of 2026 is the later instrument and supersedes it for the services it lists.
  • Radio type-approval fees are charged by the TRA (BHD 100 application, BHD 10 renewal and BHD 80 modification for telecommunications equipment; BHD 50 / 10 / 40 for terminal devices and for short range devices) and form no part of this NHRA record β€” see unresolved.radioTypeApprovalFees.
  • The Supreme Council for Environment publishes no amount for its ionizing-radiation permits; its service page states only that the fee depends on the type and number of ionizing radiation sources, so no amount for it is published here.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    NHRA Circular No. (15) of 2026 β€” Updated Fee Schedules of services and requests for medical devices and products in the National Health Regulatory Authority, Annex 1 (Tables 1-4)

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/Circulars/circular%20no%2015%20-%202026.pdf

    Effective Date

    2026-05-01

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences Β· 1 record
Open Bahrain certifications β†’
Slug

bahrain

Market

Bahrain

Confidence

high

Schemes
  • Id

    nhra-quality-assurance-certificate

    Name

    NHRA Quality Assurance Certificate β€” CE marking or FDA Certificate to Foreign Government

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Legal Manufacturer Quality System

    Note

    Registration Guideline Version 9.1, section 5, unconditional requirement 6: a Quality Assurance Certificate is required for the legal manufacturer, accepted as a CE certificate under Directive 93/42/EEC, Regulation 2017/745, Directive 98/79/EC or Regulation 2017/746, or as a US FDA Certificate to Foreign Government, with the address matching the artwork. Section 5, conditional requirement 1 adds that class III devices and class D IVDs must supply an EC Design Examination certificate or an FDA Certificate to Foreign Government, and class IIb devices must supply one if available. This is required documentation inside a full local review, not a substitute for it: the technical dossier is assessed by NHRA in full and the certificate is verified on the issuing body's website.

    Source Urls
    • https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%209.1.pdf
    Source Binding

    reviewed

  • Id

    tra-type-approval

    Name

    TRA type approval for telecommunications equipment

    Category

    Radio Spectrum

    Status

    Mandatory At Import

    Object

    Telecommunications Equipment

    Note

    Article 6(b) of the Telecommunications Regulatory Authority's Type Approval Regulation requires a Type Approval Certificate to be obtained from the Authority prior to supplying, importing, distributing, selling, offering for sale, using or connecting telecommunications equipment to a public telecommunications network in the Kingdom. Article 6(k) fixes the decision at fourteen working days from receipt of the completed application, or seven working days for the equipment listed in Article 6(e); Article 6(n) grants the certificate for a term of three years, renewable at the Authority's discretion. Article 6(c) exempts CE-marked private-use equipment without radiocommunications interfaces. Devices with a radio interface (for example a Bluetooth or Wi-Fi module) therefore carry a separate approval in addition to NHRA registration.

    Source Urls
    • https://www.tra.org.bh/Media/images/Type%20Approval%20Regulation%20-%20English.pdf
    • https://www.tra.org.bh/en/category/apply-for-type-approval
    Source Binding

    reviewed

  • Id

    sce-ionizing-radiation-use-permit

    Name

    SCE approval to use ionizing radiation sources

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Emitting Device Or Source

    Note

    The Supreme Council for Environment issues an 'Approval to use ionizing radiation sources' for a radiation-emitting device identified by model and serial number, or for a radioactive source identified by its chemical and physical characteristics, serial number and date of manufacture. The service page names its legal instruments as Law (7) of year 2022 regarding the environment and all ministerial decisions under it, together with Ministerial Order No. (4) of 2021 regarding the fees of the licences and services provided by the Supreme Council for Environment. Applications are filed in the Environmental Licensing System, require an existing licence to handle ionizing radiation sources plus a radiation safety and emergency plan, radiation workers' qualification and dose records and personal dosimetry, and the service delivery time is 11 working days. Service fees are not a published amount: they depend on the type and number of ionizing radiation sources.

    Source Urls
    • https://www.sce.gov.bh/en/Approvaltouseionizingradiationsources?cms=iQRpheuphYtJ6pyXUGiNqt85lzVfrABP
    • https://www.sce.gov.bh/en/RadiationProtection?cms=iQRpheuphYtJ6pyXUGiNqsb%2BWQT8FpmB
    Source Binding

    reviewed

  • Id

    nhra-ofoq-import-pre-approval

    Name

    NHRA import pre-approval through OFOQ

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Medical Device Shipment

    Note

    The NHRA Medical Device Importation Guideline, Version 11.1, requires a pre-approval to be obtained for imported medical devices through OFOQ, the Customs Affairs single-window service of the Ministry of Interior, and states that the request on OFOQ must be submitted before shipping the item so that pre-approval is granted before the shipment arrives at a Bahraini port. Circular No. (15) of 2026 prices the per-shipment import services separately, including a demurrage charge of BHD 100 per day per shipment for a device held until approval.

    Source Urls
    • https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Device%20Importation%20Guideline-%20Ver%2011.1.pdf
    Source Binding

    reviewed

Official Sources
  • Authority

    NHRA

    Topic

    Medical Devices Registration Guideline Ver 9.1 β€” dossier requirements, review clocks, variation and renewal

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/MDR_Guideline_Medical%20Device%20Registration_%20Ver%209.1.pdf

  • Authority

    TRA

    Topic

    Type Approval Regulation β€” approval and importation of telecommunications equipment connected to public telecommunications networks

    Url

    https://www.tra.org.bh/Media/images/Type%20Approval%20Regulation%20-%20English.pdf

  • Authority

    TRA

    Topic

    type approval application process, required documents, fees and processing time

    Url

    https://www.tra.org.bh/en/category/apply-for-type-approval

  • Authority

    SCE

    Topic

    Approval to use ionizing radiation sources β€” legal instruments, service delivery time and fees

    Url

    https://www.sce.gov.bh/en/Approvaltouseionizingradiationsources?cms=iQRpheuphYtJ6pyXUGiNqt85lzVfrABP

  • Authority

    SCE

    Topic

    radiation protection β€” regulation of peaceful uses of radiation and of non-ionizing radiation

    Url

    https://www.sce.gov.bh/en/RadiationProtection?cms=iQRpheuphYtJ6pyXUGiNqsb%2BWQT8FpmB

  • Authority

    NHRA

    Topic

    Medical Device Importation Guideline Ver 11.1 β€” OFOQ pre-approval before shipment

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Device%20Importation%20Guideline-%20Ver%2011.1.pdf

  • Authority

    NHRA

    Topic

    Medical Device Classification Guideline Ver 2.4 β€” device and IVD risk classes and classification requirements

    Url

    https://www.nhra.bh/Departments/MDR/MediaHandler/GenericHandler/documents/departments/MDR/guidelines/Medical%20Devices%20Classification%20Guideline%20Ver%202.4%2029%20June%202022.pdf

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